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Uroplasty, Inc.

USA · Minnetonka

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 2Class II 4Class III 2

plus 8 registration records and 8 510(k), 12 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 1Class III 1

7 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 1IIa 4IIb 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States8 registration records, 8 510(k), 12 PMA

Canada2 confirmed, 1 excluded

Manufacturer names merged into this page: Uroplasty, LLC · UROPLASTY, LLC

FDA 510(k) clearances by year

32005 · K052175

12006 · K061333

12007 · K071822

12009 · K091391

12010 · K101847

12012 · K121337

FDA listed device types

System, Vocal Cord Medialization 1Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence 1Endoscopic Injection Needle, Gastroenterology-Urology 1Dilator, Urethral 1Agent, Bulking, Injectable For Gastro-Urology Use 1Catheter, Balloon, Urethral, Drug-Coated 1Needle, Gastro-Urology 1Surgical Instruments, G-U, Manual (And Accessories) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121337	UROPLASTY RIGID ENDOSCPIC NEEDLES	2012-08-03
US	K101847	URGENT PC STIMULATOR; URGENT PC LEAD SET	2010-10-21
US	K091391	UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518	2009-06-30
CA	62557	PTQ RIGID NEEDLE	Class II
CA	63089	PTQ IMPLANTS	Class III

Uroplasty, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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